Functional Safety; Electromagnetic Compatibility (Emc) - Dräger Carina Instructions For Use Manual

For your safety and that of your patients

Functional safety

The essential performance consists in controlled
and monitored patient ventilation. The user defines
settings for the following monitoring functions:
– Minimum inspiratory ventilation flow
– Maximum airway pressure
If a set limit is exceeded, the device generates a
corresponding alarm.
The medical device is equipped with basic safety
features to reduce the possibility of patient injury
while the cause of an alarm is remedied.

Electromagnetic compatibility (EMC)

Medical electrical equipment is subject to special
precautionary measures concerning electromag-
netic compatibility. Observe the EMC information
during installation and initial operation. For further
information, see the following section: ''EMC decla-
ration'' (page 137).
Portable and mobile high-frequency communica-
tion equipment can affect medical electrical equip-
ment.
10
WARNING
Risk due to electromagnetic interference
Malfunctions that endanger the patient may
occur if no protective measures against elec-
trostatic discharge are employed in the follow-
ing situations:
– When touching the pins of connectors that
carry the ESD warning symbol.
– When establishing connections with these
connectors.
To prevent malfunctions, observe the follow-
ing measures and train the relevant person-
nel:
– Observe the ESD protective measures.
Such measures may include wearing anti-
static clothing and shoes, touching a po-
tential equalization pin before and while
making the connection, or using electrical-
ly insulating and antistatic gloves.
– Observe the requirements for the electro-
magnetic environment. Observe the fol-
lowing section: "Electromagnetic immuni-
ty" (page 137).
The medical device may only be used adjacent to
or stacked with other devices when the configura-
tion is approved by Dräger. If adjacent or stacked
use of non-approved configurations is inevitable,
verify normal operation of the medical device in the
configuration in which it will be used. In any case,
strictly observe the instructions for use of the other
devices.
Instructions for use Carina SW 3.2n